Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020766
Company: CHEPLAPHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XENICAL ORLISTAT 120MG CAPSULE;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/23/1999 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20766lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20766ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020766a.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/12/2016 SUPPL-36 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020766Orig1s036ltr.pdf
08/07/2015 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020766s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020766Orig1s035ltr.pdf
04/30/2014 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

10/16/2013 SUPPL-33 Labeling, Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020766s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020766Orig1s033ltr.pdf
04/02/2013 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

04/05/2013 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

12/17/2010 SUPPL-30 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020766s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020766s030ltr.pdf
01/20/2012 SUPPL-29 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020766s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020766s029ltr.pdf
05/25/2010 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020766s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020766s028ltr.pdf
02/11/2009 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020766s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020766s026ltr.pdf
01/05/2007 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020766s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020766s022_ltr.pdf
09/02/2005 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020766s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020766s021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020766_S021_XENICAL_CAPS_AP.pdf
07/09/2004 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20766slr020_xenical_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20766slr020ltr.pdf
10/22/2004 SUPPL-19 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20766s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20766s019ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020766_S019_XENICAL_CAPS_AP.pdf
12/12/2003 SUPPL-18 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20766se5-018_xenical_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20766se5-018ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020766_S018_XENICAL_CAPSULES_AP.pdf
02/27/2002 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/08/2002 SUPPL-13 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020766_S013_XENICAL_CAPS_AP.pdf
02/21/2002 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

12/19/2001 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

12/19/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

11/12/2001 SUPPL-9 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020766_S009_XENICAL_CAPS_AP.pdf
06/25/2001 SUPPL-7 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20766s7lbl.pdf
01/29/2001 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/09/2001 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

04/06/2000 SUPPL-4 Labeling

Label is not available on this site.

04/06/2000 SUPPL-3 Labeling

Label is not available on this site.

08/31/1999 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/07/2015 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020766s035lbl.pdf
10/16/2013 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020766s033lbl.pdf
10/16/2013 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020766s033lbl.pdf
10/16/2013 SUPPL-33 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020766s033lbl.pdf
01/20/2012 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020766s029lbl.pdf
01/20/2012 SUPPL-29 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020766s029lbl.pdf
12/17/2010 SUPPL-30 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020766s030lbl.pdf
05/25/2010 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020766s028lbl.pdf
02/11/2009 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020766s026lbl.pdf
01/05/2007 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020766s022lbl.pdf
09/02/2005 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020766s021lbl.pdf
10/22/2004 SUPPL-19 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20766s019lbl.pdf
07/09/2004 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20766slr020_xenical_lbl.pdf
12/12/2003 SUPPL-18 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20766se5-018_xenical_lbl.pdf
06/25/2001 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20766s7lbl.pdf
04/23/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20766lbl.pdf

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